Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT04867954

Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis

Led by University of Wisconsin, Madison · Updated on 2026-04-09

146

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

Sponsors

U

University of Wisconsin, Madison

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI) biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including fractional flow change in the portal vein and elevated azygos flow. End-stage liver disease (cirrhosis) is characterized by advanced fibrosis, liver failure, and portal hypertension. There are many causes of cirrhosis, including viral hepatitis, alcohol abuse, and perhaps most importantly, non-alcoholic fatty liver disease (NAFLD) and its aggressive subset, non-alcoholic steatohepatitis (NASH). 3 million new cases of end-stage liver disease (cirrhosis) are expected over the next decade. In cirrhosis, portosystemic collaterals that shunt blood away from the liver develop due to increased portal pressure. Gastroesophageal varices (GEV) are the most clinically relevant because they can cause fatal internal bleeding. GEV bleeding carries \~20% mortality at 6 weeks, and \~34% overall mortality. Identification of at-risk varices, prior to bleeding, is of paramount importance to initiate primary prophylaxis. To identify and treat at-risk patients, current guidelines recommend regular esophagogastroduodenoscopy (EGD) and variceal band ligation. Detection of high-risk GEV is key to initiating primary prophylaxis, which can reduce mortality by 50-70%. However, endoscopy is invasive and often unnecessary when no treatment is required. Therefore, the American Association for the Study of Liver Diseases has identified the development of "non-invasive markers that predict the presence of high-risk varices" as a major unmet need.

CONDITIONS

Official Title

Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years old with no known liver disease (healthy volunteers)
  • Adults over 18 years old with no liver disease and body mass index (BMI) of 35 or higher (obese volunteers)
  • Adults over 18 years old diagnosed with cirrhosis and known gastroesophageal varices
  • Adults over 18 years old diagnosed with cirrhosis (clinical validation phases)
  • Adults over 18 years old with Fontan repair and diagnosed Fontan-associated liver disease (FALD)
Not Eligible

You will not qualify if you...

  • Contraindications to MRI
  • Allergic or hypersensitivity reactions to both MRI contrast agents
  • Recent treatment for varices within the past year, including embolization or TIPS
  • Active bleeding from gastroesophageal varices
  • Known blood clots in the portal vein, splenic vein, or superior mesenteric vein
  • Large hepatocellular carcinoma (HCC) involving the portal vein
  • Need for conscious sedation for imaging (mild oral anxiolytics allowed with own prescription, prior consent, and presence of a driver)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Wisconsin, Madison

Madison, Wisconsin, United States, 53704

Actively Recruiting

Loading map...

Research Team

R

Radiology Studies

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here